Study Comparing Two Different Tablet Formulations Of Bosutinib Under Fed Conditions

Study comparing 2 formulations of bosutinib in healthy subjects.

Completed

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Tacoma, Washington, 98418, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Men or women of nonchildbearing potential age 18 to 50 years

Exclusion criteria

Any clinically significant medical condition

Treatment and study plan

SKI-606 (Bosutinib)

Drug

500 mg commercial formulation film coated tablet, administered once daily

Other names: Bosutinib

Primary outcomes

Pharmacokinetics, as measured by Cmax, AUC, tmax, t1/2

Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

A Single Dose Bioequivalence Study Comparing The Commercial Tablet Formulation To The Clinical Tablet Of Bosutinib In Healthy Subjects

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Mar 4, 2010
Registry last updated: Sep 6, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed